MAUDE Adverse Event Report: MEDTRONIC MEXICO BROCKENBROUGH¿ NEEDLE; TROCAR

Model Number EP003994S

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.The needle was returned and analyzed and no anomalies were found.(b)(4).

Event Description

It was reported that prior to an ablation procedure, the physician tested the transseptal needle (with the stylet inserted) and the dilator sheath.With the first three sheaths he reported that the needle scratched inside the dilator of the sheath and could not be used.The physician further reported that plastic particles could be seen.The fourth sheath indicated no issues, but after the sheath was inserted in the patient the physician was unable to insert the transseptal needle anymore.The sheath was exchanged and no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the brockenbrough needle, ep003994s with lot number 209002496, was returned and analyzed.The needle was inserted into the dilator, slight resistance was felt and plastic particles were observed after the needle exited the distal end of the dilator.There were no anomalies found with the needle.However, it is plausible that skiving occurred as there is a compatibility issue with the brockenbrough needle and a competitor sheath.The cause of the issue was not established.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BROCKENBROUGH¿ NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5118693
• MDR Text Key: 27557207
• Report Number: 9612164-2015-01583
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2016
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 209002496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1